Cleared Traditional

AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray

K172062 · Medscience Science Research Group, Inc. · General Hospital

Mar 2018

Decision

241d

Days

Class 2

Risk

About This 510(k) Submission

K172062 is an FDA 510(k) clearance for the AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray, a Allergen And Vaccine Delivery Needles (Class II — Special Controls, product code SCL), submitted by Medscience Science Research Group, Inc. (Delray Beach, US). The FDA issued a Cleared decision on March 5, 2018, 241 days after receiving the submission on July 7, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number	K172062 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 2017
Decision Date	March 05, 2018
Days to Decision	241 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	SCL — Allergen And Vaccine Delivery Needles
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5570
Definition	An Allergen Delivery Needle Is A Device Intended To Percutaneously Deliver Diagnostic Allergenic Extracts For Use In Allergy Skin Tests Also Referred To As Skin Prick Tests Or Intradermal Allergy Tests.